Clinical trials: Complication of Dialysis
Kidney Disease, Chronic Kidney Disease
Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease
The purpose of this study is to determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.
- Trial name
- NCT00093977
- Testing
- darbepoetin alfa SF
- Volunteers
- 1,100 people
- Sponsor
- Amgen
Hyperphosphatemia, Chronic Kidney Disease
Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients
This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.
- Trial name
- SBR759 (NCT01069692)
- Testing
- SBR759A
- Where
- 9 sites in Belgium, Italy
- Volunteers
- 115 people
- Sponsor
- Novartis
Anemia, End Stage Renal Disease (ESRD)
Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis
This study was conducted to explore a new therapy for anemia in participants with end stage renal disease (ESRD) on dialysis. Anemia is a reduced number of red blood cells or hemoglobin.
- Trial name
- Pyrenees (NCT02278341)
- Testing
- Roxadustat, Epoetin alfa, Darbepoetin alfa
- Where
- 143 sites in Belgium, Bulgaria and 15 more
- Volunteers
- 838 people
- Sponsor
- Astellas Pharma Europe B.V.
Chronic Kidney Disease, Renal Failure Chronic Requiring Hemodialysis
Specific Enteral Nutrition in Malnourished, Dialysis Patients With Chronic Kidney Disease. Efficacy, Safety, Quality of Life
The objective of this unblinded study is to assess the nutritional effects of a 12 weeks administration of the specific enteral nutrition (SEN) RealDiet®Renal pockets, as well as the impact on the patients' quality of life.
- Conditions
- Chronic Kidney Disease, Renal Failure Chronic Requiring Hemodialysis, Severe Malnutrition, Tolerance
- Trial name
- AL-EN-PHED (NCT01946841)
- Testing
- RealDiet®Renal
- Where
- France
- Sponsor
- Lactalis
Chronic Renal Failure, Chronic Kidney Disease
Extension Study to Evaluate Safety and Tolerability of Peginesatide for Long-Term Treatment of Anemia in Participants With CKD
The purpose of this study was to evaluate the long term safety and tolerability of peginesatide for the maintenance of hemoglobin in participants with chronic kidney disease (CKD) who had received at least 24 weeks of…
- Conditions
- Chronic Renal Failure, Chronic Kidney Disease, Anemia
- Trial name
- NCT00372489
- Testing
- peginesatide
- Where
- 9 sites in United States
- Volunteers
- 81 people
- Sponsor
- Affymax
Chronic Kidney Disease
Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.
Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney Disease (CKD) subjects receiving HX575 epoetin alfa…
- Trial name
- EPO-PASS (NCT00632125)
- Testing
- HX575 recombinant human erythropoietin alfa
- Where
- 114 sites in Austria, Bulgaria and 8 more
- Volunteers
- 1,695 people
- Sponsor
- Sandoz
Renal Insufficiency
Clinical Assessment of a New Catheter Surface Coating With Antimicrobial Properties
The study investigates the efficacy of a catheter with antibacterial surface coating in preventing central venous catheter related infection and the effect of an intensive hygiene and catheter care education of the nursing staff…
- Trial name
- NCT00621712
- Testing
- GamCath® central venous catheter, GamCath Dolphin® Protect central venous catheter
- Where
- Germany
- Volunteers
- 90 people
- Sponsor
- Vantive Health LLC
Chronic Kidney Disease, Receiving Dialysis
Study of South African Dialysis Patients
An observational study to describe the treatment of anaemia in patients with chronic kidney disease, who are receiving dialysis treatment at selected study centres in South Africa.
- Trial name
- NCT01890577
- Testing
- Aranesp
- Where
- 7 sites in South Africa
- Volunteers
- 28 people
- Sponsor
- Amgen
Anemia, Renal Insufficiency, Chronic
Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.
Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable…
- Trial name
- NCT03552393
- Testing
- Mircera
- Where
- 22 sites in United States, France and 5 more
- Volunteers
- 40 people
- Sponsor
- Hoffmann-La Roche
Renal Failure, Acute Renal Failure
Premarket Clinical Safety Assessment of the ELISIO™-HX
The primary safety objective of this study is to evaluate the safety of the use of the high-permeability hemodialyzer series ELISIO™-HX, by showing that the pre-dialysis albumin levels are not affected using the investigational…
- Conditions
- Renal Failure, Acute Renal Failure, Chronic Renal Failure, Chronic Kidney Diseases
- Trial name
- NCT07058909
- Testing
- ELISIO™-HX Dialyzer
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Nipro Medical Corporation
Anemia, Chronic Kidney Disease
Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease
The primary objectives of this study are the following: 1. To test if the proportion of participants achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is…
- Conditions
- Anemia, Chronic Kidney Disease, Kidney Disease
- Trial name
- NCT00436748
- Testing
- Darbepoetin Alfa
- Where
- 67 sites in United States, Belgium and 8 more
- Volunteers
- 116 people
- Sponsor
- Amgen
Chronic Kidney Disease
Clinical Pharmacology Study of TS-143 in Nondialysis and Hemodialysis Patients With Chronic Kidney Disease
To evaluate the safety, pharmacokinetics, and pharmacodynamics in nondialysis (ND) and hemodialysis (HD) subjects with Chronic Kidney Disease (CKD) who receive a single administration of TS-143.
- Trial name
- NCT03581071
- Testing
- TS-143
- Where
- Japan
- Volunteers
- 29 people
- Sponsor
- Taisho Pharmaceutical Co., Ltd.
End Stage Renal Disease
Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis
The purpose of this study is to compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on…
- Trial name
- NCT01195246
- Testing
- HEPLISAV, Engerix-B, Fendrix
- Where
- 19 sites in Germany
- Volunteers
- 155 people
- Sponsor
- Dynavax Technologies Corporation
Renal Failure
Pharmacokinetic Profile and Pharmacodynamic Characteristics of a Furosemide High Dosage Formulation in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis
Primary Objective: To determine the absolute bioavailability of furosemide 500 mg (Lasix® Special) oral formulation in patients with chronic renal failure undergoing peritoneal dialysis.
- Trial name
- NCT01724788
- Testing
- FUROSEMIDE, FUROSEMIDE (HOE058)
- Where
- Canada
- Volunteers
- 12 people
- Sponsor
- Sanofi
Chronic Kidney Disease, Anemia
Study of the Safety and Effectiveness of Rilonacept (IL-1 Trap) Administered Subcutaneously in Subjects With Non Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) and Anemia
Anemia of inflammation is a common complication in patients with chronic kidney disease (CKD). Patients with CKD and anemia of inflammation also exhibit decreased response to erythropoietic agents, even in the presence of…
- Trial name
- NCT00609544
- Testing
- Rilonacept
- Where
- 27 sites in United States
- Sponsor
- Regeneron Pharmaceuticals
End-Stage Renal Disease, Type 2 Diabetes Mellitus
A Double-Blind, Randomized, Placebo-Controlled Safety Study Evaluating the Effects of Residual Renal Function (RFF) in Patients With End-Stage Renal Disease and Type 2 Diabetes Mellitus on Peritoneal Dialysis
This study is a multi-center, double-blinded, randomized, study of bardoxolone methyl treatment in patients with End-Stage Renal Disease (ERSD) and Type 2 Diabetes Mellitus (T2DM) on peritoneal dialysis.
- Trial name
- NCT01576887
- Testing
- Bardoxolone Methyl 20 mg
- Sponsor
- Biogen
Healthy Volunteers
Effects of Ferrous Sulfate on the Pharmacokinetics of AKB-6548
The primary purpose of this study is to assess the single-dose bioavailability of AKB-6548 with ferrous sulfate relative to AKB-6548 in healthy volunteers.
- Trial name
- NCT02327546
- Testing
- AKB-6548, Ferrous Sulfate
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Akebia Therapeutics
Chronic Renal Failure
The Effect of Balance PD Solution on the Peritoneal Membrane in Patients on Automated Peritoneal Dialysis
To investigate the biocompatibility of the peritoneal dialysis (PD) solution balance in comparison to the conventional PD solution in APD(automated peritoneal dialysis) patients using the APD cycler sleep•safe.
- Trial name
- NCT01753154
- Testing
- Solution B (balance PD solution), Solution A (conventional PD solution)
- Where
- 7 sites in Poland, Spain
- Volunteers
- 25 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
End-Stage Renal Disease
Clinical Observation of the Performance of Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line in Treatments of Patients With End-Stage Renal Disease (ESRD)
The incidence and prevalence of chronic kidney disease are increasing worldwide, as is the number of patients progressing to End-Stage Renal Disease (ESRD).
- Trial name
- NCT03859830
- Testing
- Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line, AK200 Ultra S, extracorporeal circulation conduct of blood purification
- Where
- 7 sites in China
- Volunteers
- 276 people
- Sponsor
- Vantive Health LLC
Kidney Disease, Chronic
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis
This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease.
- Trial name
- NCT01318512
- Where
- Czechia
- Volunteers
- 340 people
- Sponsor
- Hoffmann-La Roche